BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3202902 · Received July 2, 2013

    Report

    Report Number
    3202902
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 18, 2013
    Report Date
    July 1, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LVAD MALFUNCTION, NON-FUNCTIONAL FOR 14 MINUTES. PATIENT CHANGED THECONTROLLER AT HOME. ADMITTED FOR OBSERVATION AND CONTROLLER CHANGE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302269 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1